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Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery
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Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
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Webinar Presentation and Transcript added to Final Guidance on Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
On Monday, August 8, 2016, the FDA will host a webinar to share information and answer questions about its final guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. This final guidance, issued on June 21, provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric…
MedSun Newsletter #122 August 2016
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Webinar – Final Guidance on General Wellness: Policy for Low-Risk Devices
On September 1, the FDA will host a webinar to share information and answer questions for manufacturers about the final guidance document titled General Wellness: Policy for Low-Risk Devices. The guidance, issued on July 28, explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use….
Executive Summary posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
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Meeting Notice: September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, Establishment of a Public Docket, Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2147] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, Establishment of a Public Docket, Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, establishment of a public docket, request for comments. SUMMARY: The Food…
Meeting materials posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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Meeting materials posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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